Neoneur Feeding System Functionality in the Clinic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-14

Study Completion Date

2024-09-14

Brief Summary

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Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

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Detailed Description

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The consented infant's assigned Speech Language Pathologist will use the Neoneur Feeding System 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. It can be used either as a special consult, or during routine care. The feeding is performed by the Speech Language Pathologist assigned to the infant. There will be no change in the infant's feeding plan. For infants consented to participate in the study, their feeding will include the Neoneur feeding system inserted between the nipple and bottle. When the Neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.

Conditions

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Feeding Patterns Feeding; Difficult, Newborn Feeding Disorder Neonatal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Feeding Assessment

Feeding assessment of High-risk premature infants

Group Type EXPERIMENTAL

Feeding Evaluation

Intervention Type OTHER

Feeding Evaluation with Device

Interventions

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Feeding Evaluation

Feeding Evaluation with Device

Intervention Type OTHER

Other Intervention Names

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Neoneur 200

Eligibility Criteria

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Inclusion Criteria

* Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =\<34 week, extubated by term
* Infants with CHD: requiring surgery during the first month of life, gestational age \> 37 weeks

Exclusion Criteria

* Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of NEC
* Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for \> 4 weeks, requiring additional surgery

Minimum Eligible Age

1 Day

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No